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Zocort

Hydrocortisone Acetate

Cream 1% Allopathic Other Topical corticosteroids

Indications

Vitiligo

Indication detailsView

The anti-inflammatory activity of Hydrocortisone Acetate is its main therapeutic property. It also has immunosuppressant and antimitotic actions. Hydrocortisone Acetate is indicated in:

Primary irritant dermatitis
Contact allergic dermatitis
Eczema: atopic, infantile, discoid, stasis
Seborrheic dermatitis
Lichen simplex and pruritus ani
Flexural psoriasis
Skin irritations, itching and rashes, for example those caused by insect bites, minor thermal burns, sunburn, etc

Therapeutic classView

Zodef

Deflazacort

Tablet 24 mg Allopathic Glucocorticoids

Indications

Allergic and inflammatory disorders

Indication detailsView

Deflazacort is indicated in-

Anaphylaxis, asthma, severe hypersensitivity reactions
Rheumatoid arthritis, juvenile chronic arthritis, polymyalgia rheumatica
Systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (other than systemic sclerosis), polyartritis nodosa, sarcoidosis
Pemphigus,bullous pemphigoid, pyoderma gangrenosum
Minimal change nephrotic syndrome, acute interstitial nephritis
Rheumatic carditis
Ulcerative colitis, Crohn's disease
Uveitis, optic neuritis
Autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura
Acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma
Immune suppression in transplantation

Therapeutic classView

Glucocorticoids

PharmacologyView

Deflazacort provides anti-inflammatory action by inhibiting Phospholipase A2 enzyme which is responsible for prostaglandin synthesis. Besides Deflazacort decreases the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals Deflazacort provides immunosuppressive action.

DosageView

Adults-

For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
Rheumatoid arthritis: The maintenance dose is usually within the range of 3-18 mg/day. The smallest effective dose should be used and increased if necessary.
Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.
Other conditions: The dose of Deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg.

Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.

The following ranges provide general guidance:

Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.
Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need.
Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25-1.0 mg/kg on alternate days.

Deflazacort withdrawal: In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.

Side effectsView

GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent Ml, thromboembolism.

ContraindicationsView

Hypersensitivity to or any of the ingredients. Patients receiving live virus immunization.

PrecautionsView

The following clinical conditions require special caution and frequent patient monitoring is necessary-

Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Glucocorticoids can cause salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary.
Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is the probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
Diabetes mellitus or family history, osteoporosis, myasthenia gravis, renal insufficiency.
Emotional instability or psychotic tendency, epilepsy.
Previous corticosteroid-induced myopathy.
Liver failure.
Hypothyroidism and cirrhosis, which may increase the glucocorticoid effect.
Ocular herpes simplex because of possible corneal perforation.

InteractionsView

Deflazacort is metabolized in the liver. It is recommended to increase the maintenance dose of Deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, (e.g. ketoconazole) it may be possible to reduce the maintenance dose of Deflazacort.

Pregnancy & lactationView

Pregnancy: Deflazacort does cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.

Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of up to 50 mg daily of Deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.

Pediatric usageView

Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Deflazacort should be carefully monitored and adjusted to the minimum effective dose.

Renal Impairment: In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.

Elderly: In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.

StorageView

Store in a cool (below 25°C) and dry place, protected from light & moisture. Keep out of the reach of children.

Zodef

Deflazacort

Tablet 6 mg Allopathic Glucocorticoids

Indications

Allergic and inflammatory disorders

Indication detailsView

Deflazacort is indicated in-

Anaphylaxis, asthma, severe hypersensitivity reactions
Rheumatoid arthritis, juvenile chronic arthritis, polymyalgia rheumatica
Systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (other than systemic sclerosis), polyartritis nodosa, sarcoidosis
Pemphigus,bullous pemphigoid, pyoderma gangrenosum
Minimal change nephrotic syndrome, acute interstitial nephritis
Rheumatic carditis
Ulcerative colitis, Crohn's disease
Uveitis, optic neuritis
Autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura
Acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma
Immune suppression in transplantation

Therapeutic classView

Glucocorticoids

PharmacologyView

Deflazacort provides anti-inflammatory action by inhibiting Phospholipase A2 enzyme which is responsible for prostaglandin synthesis. Besides Deflazacort decreases the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals Deflazacort provides immunosuppressive action.

DosageView

Adults-

For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
Rheumatoid arthritis: The maintenance dose is usually within the range of 3-18 mg/day. The smallest effective dose should be used and increased if necessary.
Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.
Other conditions: The dose of Deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg.

Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.

The following ranges provide general guidance:

Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.
Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need.
Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25-1.0 mg/kg on alternate days.

Deflazacort withdrawal: In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.

Side effectsView

GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent Ml, thromboembolism.

ContraindicationsView

Hypersensitivity to or any of the ingredients. Patients receiving live virus immunization.

PrecautionsView

The following clinical conditions require special caution and frequent patient monitoring is necessary-

Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Glucocorticoids can cause salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary.
Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is the probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
Diabetes mellitus or family history, osteoporosis, myasthenia gravis, renal insufficiency.
Emotional instability or psychotic tendency, epilepsy.
Previous corticosteroid-induced myopathy.
Liver failure.
Hypothyroidism and cirrhosis, which may increase the glucocorticoid effect.
Ocular herpes simplex because of possible corneal perforation.

InteractionsView

Deflazacort is metabolized in the liver. It is recommended to increase the maintenance dose of Deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, (e.g. ketoconazole) it may be possible to reduce the maintenance dose of Deflazacort.

Pregnancy & lactationView

Pregnancy: Deflazacort does cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.

Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of up to 50 mg daily of Deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.

Pediatric usageView

Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Deflazacort should be carefully monitored and adjusted to the minimum effective dose.

Renal Impairment: In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.

Elderly: In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.

StorageView

Store in a cool (below 25°C) and dry place, protected from light & moisture. Keep out of the reach of children.

Zodin

Ranitidine Hydrochloride

Syrup 75 mg/5 ml Allopathic H2 receptor antagonist

Indications

Zollinger-Ellison syndrome

Indication detailsView

Ranitidine is indicated in:

Treatment of active duodenal ulcer
Benign gastric ulcer
Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
Post operative stress ulcer.
Zollinger-Ellison Syndrome.
Gastroesophageal reflux disease (GERD).
Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
Recurrent haemorrhage in patients with bleeding peptic ulcer.
Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.

Therapeutic classView

H2 receptor antagonist

PharmacologyView

Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.

DosageView

Ranitidine Tablet & Syrup:

Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

Maintenance: 150 mg at night for preventing recurrences.

Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.

Ranitidine IV injection & IV Infusion:

Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.

Side effectsView

Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.

ContraindicationsView

Patients hypersensitive to Ranitidine

PrecautionsView

Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.

InteractionsView

Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.

Pregnancy & lactationView

Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.

Pediatric usageView

Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.

Overdose effectsView

Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.

ReconstitutionView

Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

StorageView

Store in a cool and dry place. protect from light.

Zodin

Ranitidine Hydrochloride

Tablet 150 mg Allopathic H2 receptor antagonist

Indications

Zollinger-Ellison syndrome

Indication detailsView

Ranitidine is indicated in:

Treatment of active duodenal ulcer
Benign gastric ulcer
Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
Post operative stress ulcer.
Zollinger-Ellison Syndrome.
Gastroesophageal reflux disease (GERD).
Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
Recurrent haemorrhage in patients with bleeding peptic ulcer.
Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.

Therapeutic classView

H2 receptor antagonist

PharmacologyView

Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.

DosageView

Ranitidine Tablet & Syrup:

Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.

Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.

Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.

Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.

Maintenance: 150 mg at night for preventing recurrences.

Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.

Ranitidine IV injection & IV Infusion:

Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.

In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.

Side effectsView

Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.

ContraindicationsView

Patients hypersensitive to Ranitidine

PrecautionsView

Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.

InteractionsView

Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.

Pregnancy & lactationView

Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.

Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.

Pediatric usageView

Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.

Overdose effectsView

Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.

ReconstitutionView

Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.

Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.

StorageView

Store in a cool and dry place. protect from light.

Zofen

Pizotifen

Tablet 0.5 mg Allopathic Other drugs for migraine

Indications

Migraine

Indication detailsView

Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.

Therapeutic classView

Anti-histamine Preparations, Other drugs for migraine

PharmacologyView

Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.

DosageView

Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.

Side effectsView

The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.

ContraindicationsView

Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.

PrecautionsView

Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.

InteractionsView

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.

Pregnancy & lactationView

Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Zofen TS

Pizotifen

Tablet 1.5 mg Allopathic Other drugs for migraine

Indications

Migraine

Indication detailsView

Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.

Therapeutic classView

Anti-histamine Preparations, Other drugs for migraine

PharmacologyView

Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.

DosageView

Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.

Side effectsView

The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.

ContraindicationsView

Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.

PrecautionsView

Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.

InteractionsView

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.

Pregnancy & lactationView

Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Zofra

Ondansetron

Oral Solution 4 mg/5 ml Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:

Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
Prevention and treatment of post-operative nausea and vomiting.
Prevention of radiotherapy-induced nausea and vomiting.

Therapeutic classView

Anti-emetic drugs

PharmacologyView

Ondansetron is a potent, highly selective 5HT₃ receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT₃ receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT₃ receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

DosageView

Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):

8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Radiotherapy-Induced Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Postoperative Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
4 mg orodispersible tablet: 16 mg
Injection: 4 mg

Pediatrics (>40 kg): Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg

Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:

Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.

Pediatric (4-11 years): 5 ml (4 mg) Ondansetron Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.

Oral solution:

Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia

Oral Soluble Film:

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

AdministrationView

Administration of Oral Soluble Film:

Step 1: Tear the pouch carefully along with the edge tear mark.
Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
Step 3: Do not chew or swallow the film whole.
Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
Step 5: Wash your hands after taking Onsaf oral soluble film

Side effectsView

Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.

ContraindicationsView

Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.

PrecautionsView

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

InteractionsView

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.

Pregnancy & lactationView

Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.

Pediatric usageView

Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.

Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.

4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.

Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.

StorageView

Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.

Zofra

Ondansetron

IM/IV Injection 8 mg/4 ml Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:

Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
Prevention and treatment of post-operative nausea and vomiting.
Prevention of radiotherapy-induced nausea and vomiting.

Therapeutic classView

Anti-emetic drugs

PharmacologyView

Ondansetron is a potent, highly selective 5HT₃ receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT₃ receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT₃ receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

DosageView

Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):

8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Radiotherapy-Induced Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Postoperative Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
4 mg orodispersible tablet: 16 mg
Injection: 4 mg

Pediatrics (>40 kg): Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg

Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:

Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.

Pediatric (4-11 years): 5 ml (4 mg) Ondansetron Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.

Oral solution:

Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia

Oral Soluble Film:

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

AdministrationView

Administration of Oral Soluble Film:

Step 1: Tear the pouch carefully along with the edge tear mark.
Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
Step 3: Do not chew or swallow the film whole.
Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
Step 5: Wash your hands after taking Onsaf oral soluble film

Side effectsView

Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.

ContraindicationsView

Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.

PrecautionsView

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

InteractionsView

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.

Pregnancy & lactationView

Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.

Pediatric usageView

Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.

Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.

4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.

Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.

StorageView

Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.

Zofra ODT

Ondansetron

Dispersible Tablet 8 mg Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:

Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
Prevention and treatment of post-operative nausea and vomiting.
Prevention of radiotherapy-induced nausea and vomiting.

Therapeutic classView

Anti-emetic drugs

PharmacologyView

Ondansetron is a potent, highly selective 5HT₃ receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT₃ receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT₃ receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

DosageView

Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):

8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Radiotherapy-Induced Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Postoperative Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
4 mg orodispersible tablet: 16 mg
Injection: 4 mg

Pediatrics (>40 kg): Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg

Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:

Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.

Pediatric (4-11 years): 5 ml (4 mg) Ondansetron Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.

Oral solution:

Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia

Oral Soluble Film:

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

AdministrationView

Administration of Oral Soluble Film:

Step 1: Tear the pouch carefully along with the edge tear mark.
Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
Step 3: Do not chew or swallow the film whole.
Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
Step 5: Wash your hands after taking Onsaf oral soluble film

Side effectsView

Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.

ContraindicationsView

Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.

PrecautionsView

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

InteractionsView

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.

Pregnancy & lactationView

Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.

Pediatric usageView

Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.

Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.

4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.

Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.

StorageView

Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.

Zofra ODT

Ondansetron

Dispersible Tablet 4 mg Allopathic Anti-emetic drugs

Indications

Post-operative nausea and vomiting

Indication detailsView

Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:

Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
Prevention and treatment of post-operative nausea and vomiting.
Prevention of radiotherapy-induced nausea and vomiting.

Therapeutic classView

Anti-emetic drugs

PharmacologyView

Ondansetron is a potent, highly selective 5HT₃ receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT₃ receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT₃ receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

DosageView

Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):

8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Radiotherapy-Induced Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.

Postoperative Nausea and Vomiting-
Adults:

8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
4 mg orodispersible tablet: 16 mg
Injection: 4 mg

Pediatrics (>40 kg): Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg

Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:

Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.

Pediatric (4-11 years): 5 ml (4 mg) Ondansetron Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.

Oral solution:

Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):

20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia

Oral Soluble Film:

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia.

AdministrationView

Administration of Oral Soluble Film:

Step 1: Tear the pouch carefully along with the edge tear mark.
Step 2: Put the Ondansetron film on top of your tongue. It will dissolve within 20 seconds
Step 3: Do not chew or swallow the film whole.
Step 4: Swallow after the Onsaf oral soluble film dissolves. You may swallow the dissolved film with or without liquid.
Step 5: Wash your hands after taking Onsaf oral soluble film

Side effectsView

Frequently reported adverse events were headache, constipation and diarrhea, but the majority have been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports to a sensation of flushing or warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, brochospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There have been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definitive clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.

ContraindicationsView

Contraindicated in patients known to have hypersensitivity to the drug or any of its components. Concomitant use of apomorphine.

PrecautionsView

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.

InteractionsView

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondasetron is recommended for patients on these drugs.

Pregnancy & lactationView

Carcinogenic effects were not seen in 2-year studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing women.

Pediatric usageView

Dosage Adjustment for Patients With Impaired Renal Function: The dosage recommendation is the same as for the general population.

Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.

4 years of age or younger: Little information is available about dosage in pediatric patients 4 years of age or younger.

Over the age of 65: Dosage adjustment is not needed in patients over the age of 65.

StorageView

Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.

Zoladin

Brinzolamide + Brimonidine Tartrate

Ophthalmic Suspension 1%+0.2% Allopathic Drugs for miotics and glaucoma

Indications

Open angle glaucoma

Indication detailsView

This is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Therapeutic classView

Drugs for miotics and glaucoma

PharmacologyView

Brinzolamide is a carbonic anhydrase inhibitor which reduce intraocular pressure (IOP) by decreasing aqueous humor secretion in the ciliary processes of the eye.

Brimonidine Tartrate is an alpha 2 adrenergic receptor agonist which reduces IOP by decreasing aqueous humor production and increasing uveoscleral outflow.

DosageView

Instill one drop in the affected eye(s) three times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Shake well before use.

Side effectsView

The most commonly reported side effects include blurred vision, eye irritation, bad taste and dry mouth.

ContraindicationsView

It is contraindicated in patients who are hypersensitivity to Brinzolamide, Brimonidine Tartrate, or to any ingredient in the formulation and Neonates and Infants (under the age of 2 years).

PrecautionsView

Shake well before use. For ophthalmic use only. Contact lenses should be removed during instillation of Brinzolamide and Brimonidine Tartrate ophthalmic suspension, but may be reinserted 15 minutes after instillation.

InteractionsView

In patients treated with this drop rare instances to drug interactions have occurred with high-dose salicylate therapy, CNS Depressants, Antihypertensives/ Cardiac Glycosides, Tricyclic Antidepressants, Monoamine Oxidase Inhibitors. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide + Brimonidine Tartrate .

Pregnancy & lactationView

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide and Brimonidine Tartrate ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether Brinzolamide or Brimonidine Tartrate are excreted in human milk. Caution should be exercised while giving this ophthalmic suspension to a nursing mother.

Pediatric usageView

Use in children: Safety & effectiveness in children below the age of 2 years have not been established.

Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

Overdose effectsView

Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following an oral overdose of Brinzolamide. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Very limited information exists on accidental ingestion of Brimonidine Tartrate in adults; the only adverse event reported to date has been hypotension. Symptoms of Brimonidine Tartrate overdose have been reported in neonates, infants, and children receiving Brimonidine Tartrate as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

StorageView

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than one month after first opening of the bottle. Shake well before use & do not freeze.

Zolamid

Brinzolamide

Ophthalmic Suspension 1% Allopathic Drugs for miotics and glaucoma

Indications

Open angle glaucoma

Indication detailsView

Brinzolamide Ophthalmic Suspension is indicated as monotherapy, or as adjunctive therapy to beta-blockers in the treatment of elevated intraocular pressure in ocular hypertension, or open-angle glaucoma.

Therapeutic classView

Drugs for miotics and glaucoma

PharmacologyView

Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. It exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II), found primarily in red blood cells, but also in other tissues. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fuid transport.

Following topical ocular administration, brinzolamide inhibits aqueous humor formation and reduces elevated intraocular pressure. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual feld loss.

DosageView

The recommended dose is one drops of this eye drop in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. Shake well before use.

Side effectsView

Reported side effects are blurred vision and bitter, sour or unusual taste. Other side effects are blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus and rhinitis.

ContraindicationsView

It is contraindicated in patients who are hypersensitive to any component of this product.

PrecautionsView

Brinzolamide ophthalmic suspension and its metabolite are excreted predominantly by the kidney. So, it is not recommended in severe renal impaired patients.
Brinzolamide ophthalmic suspension has not been studied in patients with hepatic impairment and should be used with caution in such patients.
The concomitant administration of Brinzolamide ophthalmic suspension and oral carbonic anhydrase inhibitor is not recommended due to no additional benefits.
If hypersensitivity reaction occurs after instillation patients should be advised to discontinue the use of Brinzolamide and consult with physicians.

InteractionsView

In patients treated with oral carbonic anhydrase inhibitors, rare instances to drug interactions have occurred with high-dose salicylate therapy. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide.

Pregnancy & lactationView

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide 1% ophthalmic suspension should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether Brinzolamide 1% ophthalmic suspension is excreted in human milk. So, lactating mother should discontinue nursing or to discontinue the drug, depending upon the importance of the drug to the mother.

Overdose effectsView

Although no human data are available, electrolyte imbalance, development of an acidosis state, and possible nervous system effects may occur following oral administration of an overdose. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

StorageView

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than four weeks after first opening of the bottle. Protect from freezing.

Zolamid Plus

Brinzolamide + Brimonidine Tartrate

Ophthalmic Suspension 1%+0.2% Allopathic Drugs for miotics and glaucoma

Indications

Open angle glaucoma

Indication detailsView

This is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Therapeutic classView

Drugs for miotics and glaucoma

PharmacologyView

Brinzolamide is a carbonic anhydrase inhibitor which reduce intraocular pressure (IOP) by decreasing aqueous humor secretion in the ciliary processes of the eye.

Brimonidine Tartrate is an alpha 2 adrenergic receptor agonist which reduces IOP by decreasing aqueous humor production and increasing uveoscleral outflow.

DosageView

Instill one drop in the affected eye(s) three times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Shake well before use.

Side effectsView

The most commonly reported side effects include blurred vision, eye irritation, bad taste and dry mouth.

ContraindicationsView

It is contraindicated in patients who are hypersensitivity to Brinzolamide, Brimonidine Tartrate, or to any ingredient in the formulation and Neonates and Infants (under the age of 2 years).

PrecautionsView

Shake well before use. For ophthalmic use only. Contact lenses should be removed during instillation of Brinzolamide and Brimonidine Tartrate ophthalmic suspension, but may be reinserted 15 minutes after instillation.

InteractionsView

In patients treated with this drop rare instances to drug interactions have occurred with high-dose salicylate therapy, CNS Depressants, Antihypertensives/ Cardiac Glycosides, Tricyclic Antidepressants, Monoamine Oxidase Inhibitors. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide + Brimonidine Tartrate .

Pregnancy & lactationView

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide and Brimonidine Tartrate ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether Brinzolamide or Brimonidine Tartrate are excreted in human milk. Caution should be exercised while giving this ophthalmic suspension to a nursing mother.

Pediatric usageView

Use in children: Safety & effectiveness in children below the age of 2 years have not been established.

Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

Overdose effectsView

Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following an oral overdose of Brinzolamide. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Very limited information exists on accidental ingestion of Brimonidine Tartrate in adults; the only adverse event reported to date has been hypotension. Symptoms of Brimonidine Tartrate overdose have been reported in neonates, infants, and children receiving Brimonidine Tartrate as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

StorageView

Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than one month after first opening of the bottle. Shake well before use & do not freeze.

Zolat

Omeprazole

Capsule (Delayed Release) 40 mg Allopathic Proton Pump Inhibitor

Indications

Zollinger-Ellison syndrome

Indication detailsView

Omeprazole is indicated for the treatment of-

Gastric and duodenal ulcer
NSAID-associated duodenal and gastric ulcer
As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
Gastro-esophageal reflux disease
Long-term management of acid reflux disease
Acid-related dyspepsia
Severe ulcerating reflux esophagitis
Prophylaxis of acid aspiration during general anesthesia
Zollinger-Ellison syndrome
Helicobacter pylori-induced peptic ulcer.

Therapeutic classView

Proton Pump Inhibitor

PharmacologyView

Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H⁺/K⁺ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.

DosageView

Oral-

Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
Long-term management of acid reflux disease: 10-20 mg daily.
Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.

IV Injection-

Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.

AdministrationView

Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.

Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.

Side effectsView

Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

ContraindicationsView

Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

PrecautionsView

When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.

InteractionsView

Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.

Pregnancy & lactationView

US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Zolat

Omeprazole

Capsule (Delayed Release) 20 mg Allopathic Proton Pump Inhibitor

Indications

Zollinger-Ellison syndrome

Indication detailsView

Omeprazole is indicated for the treatment of-

Gastric and duodenal ulcer
NSAID-associated duodenal and gastric ulcer
As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
Gastro-esophageal reflux disease
Long-term management of acid reflux disease
Acid-related dyspepsia
Severe ulcerating reflux esophagitis
Prophylaxis of acid aspiration during general anesthesia
Zollinger-Ellison syndrome
Helicobacter pylori-induced peptic ulcer.

Therapeutic classView

Proton Pump Inhibitor

PharmacologyView

Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H⁺/K⁺ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.

DosageView

Oral-

Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
Long-term management of acid reflux disease: 10-20 mg daily.
Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.

IV Injection-

Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.

AdministrationView

Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.

Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.

Side effectsView

Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.

ContraindicationsView

Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.

PrecautionsView

When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.

InteractionsView

Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.

Pregnancy & lactationView

US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Zolax

Alprazolam

Tablet 0.5 mg Allopathic Benzodiazepine sedatives

Indications

Vestibular neuritis

Indication detailsView

Alprazolam is indicated in-

Anxiety disorder
Short term relief of anxiety
Anxiety associated with depression
Panic disorder, with or without agoraphobia.

Therapeutic classView

Benzodiazepine sedatives

PharmacologyView

Alprazolam is a triazole analog of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alprazolam is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA)- benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose-related CNS depressant activity varying from mild impairment of task performance to hypnosis.

DosageView

Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. The maximum dose should not exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.

Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.

In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.

Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.

Side effectsView

Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light-headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation, etc.

PrecautionsView

Because Alprazolam may produce psychological and physical dependence, the increment of dose or abrupt discontinuation of Alprazolam therapy should not be done without the physician's advice. The duration of therapy must be determined by the physicians. Alprazolam should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency, or sleep apnea.

InteractionsView

The CNS-depressant action of Alprazolam may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral ontraceptives.

Pregnancy & lactationView

Alprazolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy. Like other benzodiazepines, Alprazolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alprazolam.

Pediatric usageView

The safety and effectiveness of Alprazolam in individuals below 18 years of age have not been established.

Overdose effectsView

Manifestations of Alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes, and coma. In such cases of overdosage general supportive measures should be employed along with immediate gastric lavage.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Zolax

Alprazolam

Tablet 0.25 mg Allopathic Benzodiazepine sedatives

Indications

Vestibular neuritis

Indication detailsView

Alprazolam is indicated in-

Anxiety disorder
Short term relief of anxiety
Anxiety associated with depression
Panic disorder, with or without agoraphobia.

Therapeutic classView

Benzodiazepine sedatives

PharmacologyView

Alprazolam is a triazole analog of the 1,4-benzodiazepine class of drugs. It is an anxiolytic with hypnotic and anticonvulsive properties. Alprazolam is presumed to produce its effects via interacting with the Gamma Aminobutyric Acid (GABA)- benzodiazepine receptor complex. Like all benzodiazepines, it causes a dose-related CNS depressant activity varying from mild impairment of task performance to hypnosis.

DosageView

Treatment should be initiated with a dose of 0.25 to 0.5 mg three times daily. Depending on the response, dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg/day. The maximum dose should not exceed 4 mg/day. Occasional patients with panic disorder may need as much as 10 mg a day to achieve a successful response and in these cases periodic reassessment and consideration of dosage adjustment is required.

Dosage should be individualized for maximum beneficial effect with the lowest possible dose. If side-effects occur at starting dose, dose may be lowered. When discontinuing therapy, dosage should be reduced gradually by no more than 0.5 mg every three days.

In elderly patients or in patients with advanced liver disease, the usual starting dose is 0.25 mg, two or three times daily and may be gradually increased if needed and tolerated.

Alprazolam 1 mg should be administered once daily, preferably in the morning by patients who are on multiple dosage regimens of Alprazolam 0.25/0.5 mg. The tablets should be taken intact, they should not be chewed, crushed, or broken.

Side effectsView

Side effects, if occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. The most frequent side effects are drowsiness and light-headedness. The other side effects, that may occur include depression, headache, confusion, dry mouth, constipation, etc.

PrecautionsView

Because Alprazolam may produce psychological and physical dependence, the increment of dose or abrupt discontinuation of Alprazolam therapy should not be done without the physician's advice. The duration of therapy must be determined by the physicians. Alprazolam should be administered with caution to patients with hepatic or renal disease, chronic pulmonary insufficiency, or sleep apnea.

InteractionsView

The CNS-depressant action of Alprazolam may be aggravated by concomitant use of other psychotropic drugs, anticonvulsants, antihistaminics, alcohol and oral ontraceptives.

Pregnancy & lactationView

Alprazolam has been categorized in pregnancy category D; that means, it should be avoided in pregnancy. Like other benzodiazepines, Alprazolam is assumed to be excreted in breast milk. Therefore, nursing should not be undertaken by mothers who must use Alprazolam.

Pediatric usageView

The safety and effectiveness of Alprazolam in individuals below 18 years of age have not been established.

Overdose effectsView

Manifestations of Alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes, and coma. In such cases of overdosage general supportive measures should be employed along with immediate gastric lavage.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Zolecon

Econazole Nitrate

Cream 1% Allopathic Topical Antifungal preparations

Indications

Vulvovaginal candidiasis

Indication detailsView

Econazole Nitrate is indicated for topical application-

In the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum,
In the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

Therapeutic classView

Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations

PharmacologyView

Econazole Nitrate interferes with fungal oxidative enzymes to cause lethal accumulation of H₂O₂. They also reduce the formation of ergosterol, an important constituent of fungal cell wall.

DosageView

Econazole vaginal tablet: One tablet should be inserted deep into the vagina at bed time for three consecutive nights. Treatment should be continued even if menstruation occurs. Although a three night course of treatment is often sufficient longer courses are advisable for women with recurrent vaginal infections.

Econazole 30 gm cream: The supplied applicator should be filled with econazole cream and then inserted deep into the vagina at bedtime once or twice daily.

Econazole 10 gm cream: Apply sparingly to the affected area once or twice daily until improvement occurs.

Sufficient Econazole cream should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

Side effectsView

During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream reported side
effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of a pruritic rash has also been reported.

ContraindicationsView

Econazole is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

PrecautionsView

Econazole nitrate is not for ophthalmic use. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. For external use only. Avoid introduction of Econazole Nitrate Cream into the eyes.

InteractionsView

Warfarin: Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econzole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.

Carcinogenicity Studies: Long-term animal studies to determine carcinogenic potential have not been performed.

Pregnancy & lactationView

Intravaginal administration in humans has not shown prolonged gestation or other adverse reproductive effects attributable to econazole nitrate therapy.

Pregnancy Category C. Econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. The drug should be used during the second and third trimesters of pregnancy only if clearly needed.

It is not known whether econazole nitrate is excreted in human milk. Caution should be exercised when econazole nitrate is administered to a nursing woman.

Overdose effectsView

Overdosage of econazole nitrate in humans has not been reported to date.

StorageView

Do not use later than date of expiry. Keep all medicine out of the reach of children. To be dispensed only on the prescription of a registered physician.

Zoledron

Zoledronic Acid [For osteoporosis]

IV Infusion 5 mg/100 ml Allopathic Bisphosphonate preparations

Indications

Post-menopausal osteoporosis

Indication detailsView

Zoledronic Acid is indicated for the treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures; prevention of clinical fractures after a hip fracture; treatment and prevention of glucocorticoid-induced osteoporosis; treatment of osteoporosis in men and for the treatment of paget's disease of bone. Treatment should be restricted to three annual doses.

Therapeutic classView

Bisphosphonate preparations

PharmacologyView

Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption. The action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered Zoledronic acid is rapidly distributed to bone. The main molecular target of Zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase, but this does not exclude other mechanisms. There was no accumulation of the active substance in plasma after multiple doses given every 28 days. Zoledronic acid is not metabolized and is excreted unchanged via the kidney.

DosageView

Treatment of postmenopausal osteoporosis: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in women with osteoporosis if dietary intake is inadequate.

Prevention of clinical fractures after a hip fracture: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. In patients with a recent low-trauma hip fracture, it is recommended to give the first Zoledronic Acid solution for infusion two or more weeks after hip fracture repairs. It is also recommended to have a loading dose of 50,000 to 125,000 IU of Vitamin-D given orally or via intramuscular route prior to the first administration of Zoledronic Acid solution for infusion. Supplemental Calcium and Vitamin-D intake is recommended for patients treated to prevent clinical fractures after a hip fracture.

Treatment of osteoporosis in men: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in men with osteoporosis if dietary intake is inadequate.

Treatment and prevention of glucocorticoid-induced osteoporosis: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in patients with osteoporosis if dietary intake is inadequate.

Treatment of paget's disease of bone: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid. Re-treatment with Zoledronic Acid may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, in patients who failed to achieve normalization of serum alkaline phosphatase, or in patients with symptoms, as dictated by medical practice 12 months after the initial dose.

In patients with paget's disease, adequate Vitamin-D intake is recommended in association with Zoledronic Acid administration. In addition, it is strongly advised that adequate supplemental Calcium corresponding to at least 500 mg elemental Calcium twice daily is ensured in patients with paget's disease for at least 10 days following Zoledronic Acid administration.

AdministrationView

The dose of 5 mg Zoledronic acid must be administered over at least 15 minutes. Zoledronic Acid should be administered intravenously via a infusion line, given at a constant infusion rate. The infusion time must not be less than 15 minutes.

Side effectsView

The post-dose side-effects are fever, myalgia, flu-like symptoms, arthralgia and headache, the majority of which occur within the first 3 days following Zoledronic Acid administration. The majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms occurring within the first 3 days after administration of Zoledronic Acid, can be reduced with the administration of Paracetamol or Ibuprofen shortly following Zoledronic Acid administration. Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking Zoledronic Acid.

ContraindicationsView

The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates, hypocalcaemia, renal impairment (creatinine clearance <35 mL/min), current or recent uveitis, or a history of bisphosphonate-associated uveitis, pregnancy and lactation.

PrecautionsView

Patients must be appropriately hydrated prior to administration of Zoledronic Acid. This is especially important in the elderly and for patients receiving diuretic therapy. Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion. Pre-existing hypocalcaemia must be treated by adequate intake of Calcium and Vitamin-D before initiating therapy with Zoledronic Acid. Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, thyroid surgery, parathyroid surgery, intestinal Calcium malabsorption). Physicians should consider clinical monitoring for these patients.

InteractionsView

Specific drug-drug interaction studies have not been conducted with Zoledronic acid. Zoledronic acid is eliminated by renal excretion. Caution is indicated when Zoledronic Acid is administered in conjunction with drugs that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration).

Pregnancy & lactationView

Zoledronic Acid is contraindicated during pregnancy and in breast-feeding women. It is also not recommended for use in children and adolescents below 18 years of age.

Pediatric usageView

Patients with renal impairment: The use of Zoledronic Acid in patients with creatinine clearance <35 mL/min is not recommended due to limited clinical safety data in such patients. No dose adjustment is necessary in patients with creatinine clearance >35 mL/min.

Patients with hepatic impairment: No dose adjustment is required for patients with hepatic impairment.

Elderly patients: No dose adjustment is required. However, because decreased renal function occurs more commonly in the elderly, special care should be taken to monitor renal function.

Zoledronic Acid must not be mixed or given intravenously with any other medication and must be given through a separate infusion line at a constant infusion rate. If refrigerated, allow the refrigerated solution to reach room temperature before administration. Aseptic techniques must be followed during the preparation of the infusion. Any unused solution should be discarded. Only clear solution free from particles and discoloration should be used.

After opening, the solution is chemically and physically stable for at least 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. Zoledronic Acid solution for infusion must not be allowed to come into contact with any Calcium or other divalent cation-containing solutions.

Overdose effectsView

Clinical experience with acute over dosage is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral Calcium and/or an infusion of Calcium.

StorageView

Store below 30° C prior to opening. Protect from moisture and light. Zoledronic Acid must be kept out of the reach and sight of children.